Author: Luke Timmerman

Luke Timmerman wrote:

San Diego-based Amylin Pharmaceuticals (NASDAQ: AMLN), along with its partner Takeda Pharmaceuticals, said late Monday that their experimental combination of metreleptin and pramlintide is being primed for final-stage Phase III clinical development for obesity. The decision was made after Amylin and Takeda reviewed data from a full 52 weeks of follow up from patients, which showed the drug consistently helped patients lose weight. Separately, Amylin said it is halting development of another obesity drug, davalintide, after a mid-stage trial showed it wasn’t as good as the combination therapy.

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Luke Timmerman wrote:

Genocea Biosciences, a Cambridge, MA-based vaccine developer, said today it has obtained licenses to 25 pending or issued patents on herpes simplex type 2 antigens from the University of Washington and Fred Hutchinson Cancer Research Center. Those antigens could be used as  the basis for a new immune-boosting treatment for genital herpes. Genocea CEO Staph Bakali described the company’s plans to treat herpes in an interview with Xconomy in December.

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Luke Timmerman wrote:

Sage Bionetworks, a fledgling Seattle nonprofit attempting to launch an open-source biology movement, has nabbed a $6.7 million grant from the National Cancer Institute to train young scientists to learn to better use genomic data to help improve drug discovery and patient care.

The grant lasts for four years, and it may be supplemented and extended, says Sage Bionetworks founder and president Stephen Friend. Here’s how it will work: Each year, the plan is to identify two young postdoctoral physicists who have deep understanding of mathematical models and algorithms, and to pair them with two clinician/scientists at the same stage of their careers, but with deep knowledge of biology, Friend says. The vision is that these pairs will cross-fertilize each others’ thinking, so that together, they can use math and computing tools to build predictive models that can show the connections between genomic alterations, the faulty proteins that arise from them, and clinical symptoms of diseases that are the end result.

By finding the connections between underlying genotype and the phenotype, so-called network biologists will be able to create the first predictive models of disease—sort of like how engineers build predictive models of an airplane on a computer before it flies. This new kind of network approach could reduce the huge waste of time and money on drugs that fail in development, by weeding out duds early, and someday helping guide personalized treatment decisions for doctors.

But if this vision is going to become reality, it will require a culture change in biology, making it more open and less proprietary. The new training program is one key step toward making that happen.

“There will be a national competition to identify the winners of these spots in the training program. I can see this becoming like winning a MacArthur fellowship,” Friend says.

Stephen Friend

Sage made its public debut about a year ago when Friend announced he was leaving his high-profile job in charge of cancer research at Merck. Even at a company with as much money and brainpower as Merck, Friend said the problems of biology are too big for any company, and that his next quest would be to apply crowdsourcing or collective brainpower to the challenge. The organization secured $5 million in charitable commitments, and was seeded with data from Merck that represented about $150 million of R&D. Sage has since secured more support from Quintiles, the giant contract research organization, and Pfizer.

There are really three main themes Sage is pursuing in its early days, Friend says. It starts with building up its research capability through support from foundations and companies. Then comes the training component that’s being supported by the National Cancer Institute. The third theme is building up the Sage platform, in which it creates the public repository for data with common standards and annotations, proper governance, and a user interface that hopefully makes this whole thing user-friendly so a large number of scientists will actually use it. Sage hopes to make progress on that third theme at its first international congress on April 23 and 24 in San Francisco.

But as for today’s news, it’s another significant step for Sage as an organization. The nonprofit now has about 20 people, counting staff and postdocs, and the grant will allow it to grow to about 25 after it adds some more mentors for its aspiring network biologists, Friend says. Sage will now collaborate with the Fred Hutchinson Cancer Research Center in Seattle (where it is physically housed), as well as Johns Hopkins University, the Dana-Farber Cancer Institute, the University of Hong Kong, and the Netherlands Cancer Institute.

In the beginning, the research projects will focus on breast, colon, liver, and pancreatic cancer models. Researchers at Sage will build computational models of disease, and then run wet-lab experiments to see how accurate they are, and to refine their methods. The goal, over time, will be to extend this sort of training to many other centers beyond Sage, Friend says.

“We want to set up a paradigm for training. If after four years, this is the only place doing this training, it will be too bad,” Friend says.

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Luke Timmerman wrote:

Every other week, Celldex Therapeutics CEO Anthony Marucci drives four hours and 15 minutes from home in northern New Jersey to his company’s headquarters in Needham, MA. He’s racked up 60,000 miles on his Mercedes-Benz E-class going back and forth.

It sounds like the sort of extreme measure an executive might take on a temporary basis, but this is actually the new routine for the head of this small public company that’s been stitched together across two states. Celldex (NASDAQ: CLDX) was founded five years ago as a spinout from a research division of Medarex near Phillipsburg, NJ. The company took its current shape over the past couple years with acquisitions of Needham, MA-based Avant Immunotherapeutics, and Branford, CT-based Curagen. The end result is a public company with 93 employees, including 68 at sites in Needham and Fall River, MA.

After Celldex acquired Avant in 2008, the decision was made to keep Avant’s Needham offices as the headquarters. “It looks like a headquarters, feels like a headquarters. And it costs like a headquarters,” Marucci says with a laugh.

Oh, he’s tried other ways of commuting. Like flying from Newark to Logan. That experience started to make the E-Class, with the “clean-diesel” engine, start to look pretty good. “Newark to Boston is a bear. It’s actually 15 minutes faster for me to drive than to fly. It costs $600 for a plane ticket, and there’s always a delay. Then when you land you get a cab. And you need a car to go back and forth from work while you’re there. So from a cost basis, it makes sense for me to get in the car and drive.”

Celldex’s corporate strategy has begun to solidfy at the same time as Marucci’s commuting strategy has. Through the acquisitions, Celldex has assembled a pipeline of five experimental drugs that are in, or ready for, clinical trials. It has capabilities to make targeted antibody drugs, antibodies that are bound with toxins to make them more potent, vaccines, and drugs that activate or suppress the immune system in combination with other treatments.

Anthony Marucci

Celldex’s lead candidate in the clinic, CDX-110, is being developed in a partnership with Pfizer. The drug is an immune-system simulator for patients with a common type of brain cancer, glioblastoma multiforme. The bigger company is controlling development of this one—and earned that right after paying $50 million upfront—so Marucci didn’t have much to say about when investors might see results from an ongoing Phase II trial.

Further back in the pipeline, Celldex has some work going on that has flown below investors’ radar. Celldex got its hands on 11 different antibody drugs in various stages of development, some skilled drug developers, and more than $50 million in cash when it acquired Curagen last May. Investors initially cheered, but soon soured on the deal because it didn’t satisfy their short-term outlook, Marucci says.

Yet one of those assets from Curagen, an antibody that’s “empowered” by being linked to a potent toxin, showed some intriguing clinical trial results in December that may have long-term potential. The drug, now called CDX-011, was found to keep metastatic breast cancer from spreading further in 9 out of 26 patients for at least 12 weeks. This result, reported at the San Antonio Breast Cancer Symposium, was somewhat overshadowed by another souped-up antibody drug from Roche and Waltham, MA-based ImmunoGen (NASDAQ: IMGN), but it was an important step for Celldex at a prominent medical meeting.

“We were very happy with the data,” Marucci says.

By expanding into Massachusetts in 2008, what Celldex got was a team of people who should know what to do next. Celldex isn’t going to be at the mercy of outsourcing firms who may or may not hit their deadlines. “The Avant infrastructure really gives us all the preclinical, clinical development, and toxicology capabilities we need. We can do that all in house now. The synergistic aspect was that we can now control the development process,” Marucci says.

Those people are being put to the test this year, on programs like CDX-011. During our conversation Marucci made sure to use the word “randomized” several times, to point out that Celldex is graduating from exploratory, uncontrolled trials to more rigorous studies that compare patients randomly assigned to take the experimental drug to those assigned to a control group. It’s a sign, Marucci says, of a company that’s growing up, not just expanding physically in different geographies.

“By the end of 2010, we should have multiple programs in randomized later-stage studies. We have an engine for future growth. We are an antibody company,” Marucci says.

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Luke Timmerman wrote:

Gilead Sciences paid $365 million to acquire Seattle-based Corus Pharma in 2006, and now it finally can see a way of getting a return on that investment in the U.S. The world’s leading marketer of HIV medicines said late Monday that the FDA has given it clearance to start selling an inhalable antibiotic to U.S. patients with cystic fibrosis.

Foster City, CA-based Gilead (NASDAQ: GILD) said it is now approved to start selling aztreonam lysine (Cayston) to help treat a nasty bacterial infection in the lungs called P.aeruginosa. The drug received clearance in Europe and Canada last September.

“All of us at Gilead extend our thanks to the investigators and to the people with cystic fibrosis who took part in the Cayston clinical trials,” said Norbert Bischofberger, Gilead’s chief scientific officer, in a statement. “We look forward to making Cayston available to the cystic fibrosis community as soon as possible.”

The FDA approval of the new cystic fibrosis drug isn’t expected to be a big profit driver for Gilead, but it’s a big deal for the Seattle crew, because it was their baby. Gilead is looking to diversify away from its heavy reliance on HIV drugs, and as part of that, has invested $50 million in a new Seattle research center with 150 employees concentrated on lung diseases. It’s also potentially meaningful for the 30,000 people in the U.S. who have cystic fibrosis, a genetic disease in which thick, sticky mucus builds up in the lungs, which can get infected, and which usually means patients don’t live to turn 40. The new drug is the first new antibiotic for cystic fibrosis patients in more than 10 years, Gilead said.

Gilead didn’t say how much the drug will cost in its news release, and a spokeswoman didn’t immediate respond to a request for comment late Monday.

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Luke Timmerman wrote:

Arzeda CEO Michael Martino is out. Martino, the former CEO of Bothell, WA-based Sonus Pharmaceuticals, has resigned his job as CEO of the Seattle designer-enzyme startup, and plans to take a new position with a biotech company in San Diego, according to an e-mail he sent today to friends and colleagues.

Martino’s resignation is effective as of this Friday, February 26, and he will start at his new job, which he isn’t disclosing yet, on March 1. Martino will maintain a seat on Arzeda’s board.

“Paying me a competitive salary would account for a material percentage of the money we’ve been trying to raise. From the company’s perspective, given that the focus over the next twelve-to-eighteen months must be on generating data to demonstrate the technology, the use of scarce and expensive capital to pay my salary is hard to justify,” Martino wrote. “From my perspective, given that I’ve been working on behalf of the company for over a year without compensation, I simply cannot afford to discount my services.”

Arzeda was founded by three young scientists from David Baker’s biochemistry lab at the University of Washington. It was born from the idea of using computers to design enzymes that don’t exist in nature, yet could be very useful for everything from new drugs to cleaner industrial catalysts. The company had sought to raise as much as $12 million in an initial venture round a year ago, but never nailed down that much cash. The company, did, however, negotiate a license from the UW Center for Commercialization, and developed a business plan focused on industrial catalysts. It secured some undisclosed financing from a partnership with DuPont, a $149,000 six-month grant from the National Science Foundation, and about $250,000 in financing from WRF Capital.

Now that Martino is leaving, the company’s fortunes will depend on the amount of progress made in the lab by the three founders, Eric Althoff, Daniela Grabs, and Alexandre Zanghellini. Once more progress is made, the company will be in position to hire a new CEO with more specific expertise in the industrial catalyst business, says Thong Le, a managing director with WRF Capital and a director of Arzeda.

“In this environment when capital is difficult to come by, the company needs to show more scientific progress,” Le says. “This is the responsible thing to do.”

Arzeda’s founders have financial support from DuPont until July 1, 2011, and from the NSF grant until fall of 2010, when the company expects to compete for another $500,000 extension of the original grant, Martino said in his note to colleagues.

By saving on Martino’s salary, the company is positioned to raise a small round of financing, worth $500,000 to $600,000, which should last a longer period of time, Martino said.

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Luke Timmerman wrote:

Dendreon raised $630 million from investors last year to gear up for the commercial push of its new drug for prostate cancer, and the Seattle-based company plans to spend a lot of it this year.

The company (NASDAQ: DNDN) plans to use about $460 million of its cash in 2010—about triple what it burned through last year—as it builds up three factories across the country to make sipuleucel-T (Provenge). About $200 million of that will be one-time capital expenses on facilities in New Jersey, Georgia, and Southern California. Another $30 million will go toward building up inventories, while the rest will go toward salaries, benefits, consulting, and marketing activities, according to Greg Schiffman, Dendreon’s chief financial officer. Then in 2011, Dendreon expects to generate positive cash flow. Schiffman made the remarks this afternoon on the company’s quarterly conference call with analysts.

Dendreon is spending all that cash as it enters the home stretch for what analysts expect is an almost certain green light from the FDA to start selling the prostate cancer drug in the U.S. The product, Dendreon’s first as a company, is also seeking to be the first in a new class of therapies that actively stimulate the patient’s immune system to fight cancer cells. It passed a pivotal clinical trial last year of 512 men with terminal prostate cancer, showing it could help them live a median of four months longer than a placebo, with minimal side effects.

The FDA’s deadline to complete its review of the drug application is May 1. There’s about a 90 percent chance the FDA will approve this drug on time, according to JP Morgan analyst Cory Kasimov, and if so, the sales will easily exceed the spending rate by Dendreon, he says. About 80,000 men in the U.S. might be candidates for this drug, at a cost of $65,000 per patient, which means the drug could generate at least $1.5 billion in U.S. sales in 2014, Kasimov said in a note to clients today. Even though Dendreon stock touched a 52-week high of more than $33 today, Kasimov predicts it will go even higher to $46 by the end of the year.

“Dendreon’s prostate cancer vaccine Provenge has encountered more bumps than a mogul run on Cypress Mountain, but now we believe the regulatory process that’s going on four years finally appears poised to reward the perseverance,” Kasimov wrote in the note to clients today.

The big bump he’s referring to was the euphoria …Next Page »

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Luke Timmerman wrote:

The future leader of Biogen Idec might be as familiar with a petri dish as he or she is with a spreadsheet.

That’s according to Bill Young, who took over as Biogen’s chairman of the board on January 1. Young is on the board committee that’s searching to replace CEO Jim Mullen, who announced last month that he’s stepping down after a decade at the helm of the Cambridge, MA-based biotech giant (NASDAQ: BIIB). I met with Young last week while he was visiting a startup in Seattle.

“We have a whole list of criteria, but the most important of which is that we find someone who has managed and understands the role of science in a biotech company, and how that needs to be bridged to the commercial side of things,” Young says. “That may mean it’s a scientist or someone who understands how that fits into what biotech companies are designed to do, which is develop products.”

The job is one of the higher-profile gigs in biotechnology. Biogen, which also has operations in San Diego, is the world’s largest maker of multiple sclerosis drugs. It generated $4.4 billion in revenue last year, and came close to a $1 billion annual profit in 2009. Biogen had 4,750 employees worldwide heading into this year, and a stock market valuation of $15 billion that ranks it behind only Amgen, Gilead Sciences, and Celgene among biopharmaceutical industry peers.

Yet Biogen has its share of headaches. Uncertainty about the side effects of its fastest-growing multiple sclerosis drug, natalizumab (Tysabri), are a constant worry. Billionaire investor Carl Icahn ripped the company last year for poor R&D performance that he said added up to “failed leadership.” Icahn persuaded shareholders to give his slate two board seats, and he already has given notice that he wants three more in this year’s board election. This fight has gotten personal at times, like when Icahn reminded shareholders that Mullen was paid $60.8 million in total compensation, combining salary, bonus, and stock options over a five-year period, while Biogen stock declined from $66.61 to $47.63.

Bill Young

Mullen sounded battle-weary last month when he spoke at a Goldman Sachs conference about this exit: “If you’re going to have a mid-life crisis, you can do one of two or three things, right? Sports cars I’m too big for. Mistresses are not approved at home. Maybe a career change is what’s in order. I decided to go with Number 3. I think it’s a good time, for, you know, a transition.”

While Mullen looks for something else to do, he doesn’t appear to have groomed an obvious internal successor. It’s also worth noting that Mullen has a business background, not a scientific one.

“There may be some internal candidates we consider, but they are largely external,” Young says. “We have a lot of people interested. As you can imagine, there are not many large, cash flow positive biotech companies around these days. Many have been acquired or haven’t reached that stage yet. Biogen Idec is certainly one of those. There’s a lot to work with there. Good culture, strong science. Jim [Mullen] has been there 20 years, done a good job, but I think he was ready to try something else. That’s OK and appropriate. People will make that decision from time to time.”

The search committee has hired …Next Page »

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Luke Timmerman wrote:

Big decisions about the future of NanoString Technologies are in the works. The Seattle-based maker of genetic analysis tools is crafting a strategy to enter the clinical diagnostics market, it expects to hire a permanent CEO within a couple months, and it may establish its headquarters to the San Francisco Bay Area to get the right leader, according to new executive chairman Bill Young.

I met with Young while he was visiting NanoString offices in Seattle’s South Lake Union neighborhood, getting to know some of the management and staff. Young is a big name in the biotech world, as the chairman of Cambridge, MA-based Biogen Idec (NASDAQ: BIIB), the former CEO of Monogram Biosciences, and chief operating officer of Genentech. Young was introduced to NanoString by a former Genentech colleague, Nick Simon, who’s now a partner with Boston’s Clarus Ventures, which led a $30 million investment in NanoString last June.

NanoString, founded in 2004 on technology from the Institute for Systems Biology in Seattle, is now selling a tool to help biologists examine the extent to which genes are dialed on or off in a tissue sample—what’s known as gene expression analysis. The product hit the market in July 2008, and now has customers at the Broad Institute of MIT and Harvard, the National Cancer Institute, Caltech, and the University of Washington. While that may be an encouraging start, NanoString sells an expensive piece of new equipment (about $250,000), is up against some well-entrenched competitors, and has been operating without a CEO since Perry Fell resigned almost a year ago.

The top priority now, Young says, is finding permanent new leadership.

Bill Young

“There are some very good people in this company, very smart, very dedicated, intense people. One of the things they need is consistent leadership that can take the company to the next level,” Young says.

Quite a few candidates have been interviewed, and a few more still need to go through the process, Young says. He hopes to have an announcement of who the new CEO will be in 60 days. And while the decision hasn’t been made, Young says it’s possible that the new leader might be based in the San Francisco Bay Area, along with a portion of NanoString to support him or her. The company is looking for a rare blend of skills, in someone familiar with science and commercialization, in not just scientific instruments, but also in clinical diagnostics.

“We may keep some of the science operations, the manufacturing operations here, but have some of the company in the Bay Area. We’re open to that when we select the person,” Young says. When I followed up with NanoString’s interim CEO, Wayne Burns, he wanted to clarify that the company is “not moving headquarters, but building out commercial operations centered out of the Bay Area. We are building a distributed organization as this is necessary for our goal to build a very large company.”

NanoString at this point is still really a tool company. As I described in a November feature, the basic idea is to allow researchers to look at a large number of genes, with digital precision, to see the extent to which they are turned on or off in a given sample. It’s the sort of technology that’s supposed to …Next Page »

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Luke Timmerman wrote:

Just before the financial crisis hit in September 2008, Cambridge, MA-based Proteostasis Therapeutics was fortunate to snag $45 million of initial venture financing to pursue a dream. It has been pretty quiet since then. But behind the scenes, the idea has morphed into a company built to make convenient oral pills for diseases of aging.

Proteostasis was started by a big-name investor syndicate led by HealthCare Ventures. The founding science came from the San Diego labs of Jeffery Kelly at The Scripps Research Institute and Andrew Dillin at the Salk Institute for Biological Studies, and Richard Morimoto at Northwestern University. The money, and the brainpower, was supposed to rally around emerging biology that seeks to alter protein pathways that break down as people age, and lead to neurodegenerative diseases like Alzheimer’s and Parkinson’s.

“The philosophy was let’s take the leading lights in the academic field, who are defining and pushing this understanding of protein stability, and work with them and create a first-in-class, best-in-class company that is able to OWN this space. That’s the idea that went into Proteostasis, and that investors were sold on,” says Greg Licholai, the company’s chief operating officer.

The first six months or so were really nascent days, in which Proteostasis sought to precisely define goals and strategy, Licholai says. The company spent 2009 in the building phase—obtaining licenses to key intellectual property, hiring a team of 30 biologists, chemists, pharmacologists, and bioinformatics specialists. The big-name CEO from the beginning, David Pendergast, left, and chairman Chris Mirabelli of Healthcare Ventures now holds the title of interim CEO.

As the year went on, Proteostasis offered up some glimpses of its science. One paper in Nature Chemical Biology suggested an oral pill could restore partial function to lung cells from patients with cystic fibrosis. Another publication in the journal Cell showed how a pill might be able to stop the cumulative piling up of beta amyloid proteins that is thought to contribute to Alzheimer’s. A third study that Licholai told me about found that by altering a certain protein pathway in worms with Huntington’s disease, researchers could double their lifespan.

Greg Licholai

All of this research still has an extremely long way to go before it can reach a clinical trial, and Licholai didn’t want to divulge the company’s timetable for reaching that milestone. Still, the idea of altering not just one protein, but networks of proteins with convenient, oral small molecules is starting to attract attention from potential partners in the biotech and pharmaceutical industry, Licholai says.

The science of what’s happening here isn’t easy to explain in lay terms, but I’ll give it a whirl. The central dogma of biology says that DNA provides the instructional code for RNA, which makes proteins that carry out the functions in the body. Proteostasis sees itself navigating the complex intermediary steps in which the sequence for a protein is produced, but the protein still needs to pass through certain pathways to become fully functional, stable, and find its appropriate location in the cell. Sometimes these pathways degrade as we age and cause neurodegenerative diseases like Alzheimer’s, Parkinson’s, or Huntington’s. Or, the cumulative effect of high blood sugar puts stress on protein pathways, which perturbs the network, and leads to an altered state in which people develop insulin resistance and get diabetes, Licholai says. Scientists are only beginning to map out connections between these networks, and the trick will be to find the most important nodes on the network, Licholai says.

“Just like on the Internet, certain nodes have higher levels of connectivity than other nodes. Why is that important? Not all nodes are created equal. If Amazon.com loses its connectivity, that has a major effect on the network. The same thing is true from a biological point of view,” Licholai says. “Those are the ones to understand from a disease point of view, and from a drug discovery point of view.”

Anytime you start aiming a drug at a new target, especially one that’s an important crossroad for a lot of biological function, it’s obvious that a ton of work will need to be done to demonstrate this is safe. So Proteostasis is spending a lot of effort mapping …Next Page »

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Luke Timmerman wrote:

The world knows all too well that we don’t have much snow here in the Pacific Northwest (sorry, Vancouver), but we certainly felt the impact of the East Coast snowstorm here on the biotech beat over the last week.

—Seattle-based Cell Therapeutics (NASDAQ: CTIC) is waiting a little longer than expected for its judgment day. The company had prepared to make its case for approval of pixantrone as a treatment for non-Hodgkin’s lymphoma in front of an FDA advisory panel near Washington DC on February 10, but it was postponed because of the snowstorm. No word yet on when it will be rescheduled. But a couple days before the delay, FDA staff raised some concerns about how the drug has “substantial” toxicity.

—Calypso Medical Technologies, the Seattle-based company with technology for precisely targeting radiation therapy, announced this week that it has the first data from a clinical trial that shows its system can help reduce the urinary, bowel, and sexual dysfunction that’s common for men who undergo this form of treatment for prostate cancer. The Calypso system, because it helps technicians better track how the prostate moves in the body, enables technicians to use a narrower radiation beam that avoids hitting healthy tissue.

—The Seattle innovation community has never had a formal group of angel investors that specialize in medical devices, at least until recently. I wrote the story about this fledgling (sorry, bad pun) group that calls itself Wings. Wings is led by some strong entrepreneurs in the field, including Endogastric Solutions founder Stefan Kraemer, University of Washington entrepreneur-in-residence Bob Wilcox, and Pathway Medical founder Tom Clement.

—One of the veterans from the early days at Bothell, WA-based Halosource, Simon Johnston, has formed a startup to tackle a new application for some emerging antimicrobial chemistry. The company, called Antimicrobial Technologies Group, has made compression socks with a tiny dose of an antimicrobial finish, which it hopes to sell to the many patients with diabetes who develop infections in their feet, because of poor circulation.

—Chris Rivera, the president of the Washington Biotechnology & Biomedical Association, offered up a guest editorial, co-authored with life sciences guru Steve Burrill, about why they are bullish about biotech in the Northwest. They are hoping to draw “significantly more” than the 700 people who attended the WBBA’s annual life sciences showcase event last year; Life Science Innovation Northwest 2010 is scheduled for March 16 and 17.

—Cell Therapeutics isn’t the only organization that’s been stalled by the East Coast snowstorm. Gilead Sciences (NASDAQ: GILD]), the Foster City, CA-based company with a significant research center in Seattle, is still waiting for word from the FDA on whether it will approve aztreonam lysine (Cayston) as a new inhalable antibiotic for patients with cystic fibrosis. The FDA’s deadline was February 13.

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Luke Timmerman wrote:

Calypso Medical Technologies was founded a decade ago on the belief that it could reduce side effects for cancer patients getting radiation treatment. Now the Seattle-based company has the first batch of clinical trial data to prove it.

A study of 64 patients who used the Calypso system to track their prostate tumors in real-time during radiation sessions had fewer bowel-related side effects like diarrhea, as well as less urinary irritation and erectile dysfunction, researchers said this week in the journal Urology. The findings were stacked up against those from a study published two years ago in the New England Journal of Medicine that enrolled 153 similar patients who got standard radiation, without the real-time, prostate tracking feature offered by Calypso.

The Calypso system works by implanting tiny transponders in the cancerous prostate gland, which sends a signal to a base station which tracks the precise 3-D location of the prostate in real-time. By offering more precise, real-time tracking, doctors can keep the beams of radiation aimed exclusively at the cancerous target, without harming healthy bladder and rectal tissue nearby. If a patient burps or twitches on the treatment table, technicians can see immediately if the beams are off track. The more precise targeting enables doctors to use high-intensity, more narrowly focused radiation beams that could ultimately save the patient from being impotent or having to wear adult diapers the rest of their lives.

Calypso’s system was first cleared for sale in the U.S. in July 2006, based on some simple studies that showed it was safe, and roughly comparable in terms of accuracy to predecessor X-ray systems. But that didn’t really offer proof that it helps patients lead healthier lives. That’s a key question Medicare wants to see answered, as the Calypso system can cost $400,000 to $500,000 for the machine, plus $1,200 per patient for implantable transponders. Essentially, the new clinical trial data is important because it’s the first evidence that says Calypso’s technology can do what it’s supposed to do for patients.

Eric Meier

“Radiation therapy has been getting better and better throughout my career, but this really represents an additional improvement in quality of life for patients getting radiation therapy today, even when compared to just a couple years ago,” says Howard Sandler, the chair of radiation oncology at Cedars-Sinai Medical Center in Los Angeles, and the lead author of the study published in Urology.

The results were based on questionnaires the patients filled out about their quality of life two months after they completed a typical eight-week course of radiation. On a scale of 0 to 100, patients said their bowel function was rated at about 90.3 when they started the radiation treatment with the Calypso system, and 88.8 after they completed therapy—which basically means patients weren’t harmed, Sandler says. By contrast, the patients in the comparison study, who got standard radiation, saw their quality of life scores on bowel function drop by 16 points on the 100-point scale. That’s a big enough difference that Sandler says he would now advise patients not to worry about their bowel control as much if they use the Calypso system.

Of course, the study doesn’t answer every important question …Next Page »

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Luke Timmerman wrote:

It’s not every day on the biotech beat that we find a startup has been inspired by the 1984 rock mockumentary “This is Spinal Tap.” But that’s a true story behind the founding of Eleven Biotherapeutics, the latest high-profile startup in the Boston biotech cluster.

Cambridge, MA-based Eleven Biotherapeutics is emerging from stealth mode today with its volume dialed way up, as they say in the movie, past 10 on the amplifier, to 11. The company has raised $35 million in its Series A round, attracted prominent backers from Third Rock Ventures and Flagship Ventures, and assembled a five-man band of big-name scientific founders. The money and brainpower is being channeled into a company that seeks to engineer proteins with ideal properties for treating autoimmune diseases and blood clotting disorders.

Eleven is led by interim CEO Mark Levin, a founding partner with Third Rock and the former CEO of Millennium Pharmaceuticals. He’s joined by Cary Pfeffer, a partner at Third Rock, who is serving as interim chief business officer, and Burt Adelman, the former executive vice president of R&D at Biogen Idec, who is now the interim head of R&D at Eleven. I spoke with Pfeffer yesterday afternoon to get the scoop.

“We are developing substantially improved next-generation biologic drugs,” Pfeffer says. Like in the movie, “the concept is to go one better than the maximum on the amp, which is 10.”

This is all still at a very early stage. Eleven isn’t saying anything specific yet about which drugs are its lead candidates, which diseases they are designed to treat, where the intellectual property for this comes from, or exactly how far along its programs are in development. But with $35 million in hand, Eleven has the cash to hire a team of 25 to 30 people for its R&D team, and an ambitious goal of going through the early steps of development to reach a clinical trial in three years.

Mark Levin

The strategy at Eleven is to assemble a portfolio of drugs, using a wide variety of best practices in protein engineering, not just one single technology platform like many other companies, Pfeffer says. The technologies are not proprietary to Eleven. The company sees its advantage being in the scientific insights of its founders, and their ability to harness so many different protein engineering technologies to drug candidates in the pipeline, Pfeffer says.

The initial plan is to develop a number of programs with low, medium, and high risk. That means Eleven plans to acquire a couple of drug candidates that are in some early phase of clinical trials, develop some internal drug candidates that are made to hit targets that have been validated by other drugs, and then put some resources toward drugs that block higher-risk, novel targets on cells.

While protein drugs are made by incubating inside living cells—and that brings an inherent amount of unpredictability when dealing with Mother Nature—Eleven is seeking to capitalize on advances that have given scientists more control over the properties they want, and don’t want, in the protein drugs that they create.

For example, it’s now possible to engineer protein drugs from scratch so they can …Next Page »

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Luke Timmerman wrote:

San Diego has grown up into the world’s third-leading hub of life sciences over the past three decades. But what will the local life sciences landscape look like another two decades from now? Will the region have gained basic research prowess, attracted more venture financing, and stimulated more entrepreneurial activity?

I’m excited to announce that Xconomy has assembled a panel of industry visionaries from San Diego to wrestle with these questions. This event will feature a highly interactive panel discussion with Paul Schimmel of The Scripps Research Institute, Dan Bradbury of Amylin Pharmaceuticals, and Fred “Rusty” Gage of the Salk Institute. John Mendlein, the chairman of Fate Therapeutics, will moderate.

What kind of perspective do these people bring? Schimmel may not be a household name, but he is one of the most accomplished scientific founders in biotech history, having co-founded Alnylam Pharmaceuticals, Alkermes, Sirtris Pharmaceuticals, and Cubist Pharmaceuticals among others. Bradbury is the CEO of San Diego’s biggest local drug developer, which invented the first diabetes therapy that can be injected once a week. Gage has applied his groundbreaking insights into how adult brains generate new neurons to San Diego-based BrainCells, a company he co-founded, which has an intriguing new depression drug in clinical trials. Mendlein guides one of the leading stem cell companies in the country, and before that, was CEO of Adnexus Therapeutics, which sold to Bristol-Myers Squibb for more than $430 million in 2007.

After the panel, we will hear brief 3-minute “burst” presentations from executives at some of the most exciting biotech startups in San Diego. The lineup includes Ambrx, Helixis, Receptos, VentiRx Pharmaceuticals, and Biogen Idec New Ventures. Then it’s all about networking, which we’ve found is one of the highlights when we’ve done similar events in Boston and Seattle.

So if you’d like to listen in on, and even join, the conversation, mark your calendars for the evening of March 31. Registration starts at 5:15 pm, and the program will run from 6 pm to 7:30 pm, followed by an hour of networking. The event will be held at Biogen Idec’s offices in San Diego. You can see all the details on how to register by clicking here.

As those of you who attended our successful San Diego biotech event in December already know, one of the hallmarks of our events is that we believe in stimulating, highly interactive conversations between speakers and the audience. That means I’m personally going to run around with a microphone to help you pose your best inquiries to this distinguished panel. So put on your thinking caps. I look forward to seeing you there on March 31.

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Luke Timmerman wrote:

Cambridge, MA-based Ironwood Pharmaceuticals (NASDAQ: IRWD) said today that the underwriters of its IPO on February 2 have exercised all their options to buy 2.5 million additional shares. That means the company has raised an extra $28 million, and after deducting all expenses from this and the first part of the transaction, the company has netted $203 million from the IPO. JP Morgan Securities, Morgan Stanley, Credit Suisse Securities, BofA Merrill Lynch, and Wedbush PacGrow Life Sciences were the underwriters. Ironwood shares have climbed slightly since the initial price was set, closing at $11.50 yesterday.

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Luke Timmerman wrote:

People who make a living creating medical devices, like ultrasound machines or stents to prop open clogged arteries, have lived through a crummy 18 months. But that’s not discouraging a group of prominent medical device entrepreneurs from Seattle who are building the region’s first dedicated network of angel investors who have the money and expertise to bankroll new med-tech startups.

This nascent nonprofit, called Wings, is transforming from an idea into an operating entity inside the Washington Biotechnology & Biomedical Association. I heard what this is about while meeting last Friday with several key players—WBBA president Chris Rivera, Endogastric Solutions founder Stefan Kraemer, Pathway Medical founder Tom Clement, and Bob Wilcox, an entrepreneur in residence at the University of Washington. They were joined by Stephanie Barnes, a commercialization associate at WBBA who is devoting half of her work time to organizing this network.

It might not seem at first glance like the most auspicious time to invest in medical devices. The industry has been caught in a downward spiral over the past 18 months, as unemployment has risen, people have lost health insurance, and hospitals have been applying greater scrutiny than ever before to purchases of new equipment and tools. Many entrepreneurs have screamed bloody murder over a proposal to raise billions of dollars through new federal taxes on medical devices.

The Wings volunteers know that all too well. Still, they say there is money to be made in the industry, and they are filling a void by helping better connect entrepreneurs to the right people who can help them financially and operationally. Many of the people in this budding angel network are thinking hard about how devices can thrive in a more rigorous era of cost-effectiveness studies (beyond the existing requirements that devices are proven safe and effective). That’s why getting the right people engaged is so important.

“If this is going to be successful, it has to be the medical device community that drives it,” Rivera says. “If it were just the WBBA doing it, it probably wouldn’t work.”

Stefan Kraemer

The main activities of the Wings organization are to help screen business plans for medical device companies, help connect entrepreneurs with investors, and provide mentorship. Unlike more established networks like Alliance of Angels, it doesn’t have its own pot of capital to invest. Instead, it will host invitation-only investment forums for about 80 wealthy individuals who also happen to have expertise in medical devices, software, or some form of medical technology. It will be up to those individuals as to whether to put their own money to work in the startups.

The group plans to hold investing events four times a year, invite three or four entrepreneurs to give their best pitch, and hopefully spark investments in four to six new companies annually, Rivera says. Investors will vet companies in four main subsectors …Next Page »

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Luke Timmerman wrote:

Ten years have gone by since Susan Froshauer co-founded Rib-X Pharmaceuticals to create effective new antibiotics. If things break right, this will be the year her company makes some critical decisions that could ensure it lasts 10 more.

Like a lot of startup drug companies, this one is consuming a lot of time and money. The New Haven, CT-based firm raised $35 million over the past year, bringing its total financing to $158 million since its founding in 2000. Much of that cash is being set aside to test Rib-X’s lead candidate, delafloxacin, in a study of 800 patients with antibiotic-resistant infections they picked up in the hospital. If Rib-X can get help from a Big Pharma partner to start that trial on schedule this year, and it pans out, then the startup should be able to file an application to market the drug with the FDA in 2012, Froshauer says.

Rib-X’s antibiotic passed a mid-stage study of 150 patients in January 2009. The drug was well-tolerated, and helped more than 90 percent of patients become clinically cured of complex skin infections, even when more than half had dangerous and hard-to-treat MRSA infections. The treatment showed comparable effectiveness when stacked up against Pfizer’s tigecycline (Tygacil). If Rib-X can match that result in the pivotal study being planned, it could offer a new option for doctors in the constant battle against bacterial resistance. It could also be a first step for Rib-X’s transition from an R&D operation into something bigger and enduring.

“By partnering the delafloxacin asset, we’d be in a situation to continue to grow the program, and over time will allow us to have an antibiotic company,” Froshauer says.

Rib-X has been around as long as it has because of the promise of its unusual scientific approach to developing antibiotics. The vision was to use emerging technology to get high-resolution crystal structures of structures called ribosomes in bacterial cells. This is important because many different classes of antibiotics work by binding with the ribosomes. So by getting precise images, and using a proprietary computational system, Rib-X seeks to identify points where the bacteria are vulnerable, and where resistance can emerge.

While the underlying science is getting a taste of validation from clinical trials, that’s not the end goal for Rib-X as a business, Froshauer says. Other firms that have achieved some clinical validation have capitalized on that in subsequent acquisitions—San Diego-based Calixa Therapeutics, for instance, sold out last year to Lexington, MA-based Cubist Pharmaceuticals for …Next Page »

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Luke Timmerman wrote:

Helicos Biosciences (NASDAQ: HLCS), the Cambridge, MA-based maker of genetic analysis instruments, said today in a regulatory filing that president Steve Lombardi has resigned. Lombardi’s exit was official as of February 11 from his full-time job and from his position on the board of directors. Helicos didn’t say why Lombardi is leaving, but noted that it wasn’t because of a disagreement with the company over operations, policies, or practices. Lombardi will continue to earn his salary through August 31, at his annual base rate of $375,000. Lombardi had been CEO of Helicos from August 2008 to December 2008, when he was replaced in the company’s top job by Ronald Lowy.

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Luke Timmerman wrote:

The people who built Cambridge, MA-based Sirtris Pharmaceuticals on the idea of treating diseases of aging, and sold it to GlaxoSmithKline for more than $700 million two years ago, are apparently busy building a new venture capital fund.

Christoph Westphal, Michelle Dipp, and Rich Aldrich are listed as co-managers of Longwood Founders Fund, on a regulatory filing dated yesterday. The filing lists an office in Boston at the financial planning firm of JDJ Resources, as the venture capital fund’s address. The fund has raised $50.7 million so far, from 24 undisclosed investors. The news was first reported by Mass High Tech.

Dipp called to say she couldn’t comment at this point because Longwood is in the midst of ongoing fundraising, and is bound by an SEC mandated quiet period. But given their track records, whatever this fund aims to accomplish will certainly be of interest to the life sciences industry in Boston and beyond. Westphal currently has the dual role of CEO of Sirtris and senior vice president of Glaxo’s Center of Excellence in External Drug Discovery. Before that he co-founded Alnylam Pharmaceuticals, Momenta Pharmaceuticals, Acceleron Pharma, and Concert Pharmaceuticals, and was a general partner at Polaris Venture Partners. Aldrich is a co-founder of Vertex Pharmaceuticals, and a Boston hedge fund, RA Capital. Dipp, on her LinkedIn page, says that her Sirtris experience ended in 2009, and that she remains vice president and head of the Center of Excellence for External Drug Discovery at Glaxo.

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Luke Timmerman wrote:

For years, Halosource was what you might call a solution in search of a problem. It had anti-microbial technology that could theoretically kill viruses and bacteria anywhere and everywhere. But when it came down to making actual commercial products, it took many years to find its niche in purifying water.

Now one of the veterans from the early days at Bothell, WA-based Halosource, Simon Johnston, says the time has come for a few of the innovative antimicrobial applications that were too far ahead of their time. First on the list: socks.

I know, I know, what could possibly be innovative about socks? Cotton, polyester, wool, that’s all you need to know, right? It turns out Halosource spent a lot of time in the ’90s thinking about how to use technology that incorporates antimicrobial compounds into textiles. Socks, kitchen towels, bedsheets—these are all obvious fabrics used by millions of people every day, and which can become breeding grounds for hardy bugs like viruses, bacteria, or fungi.

Halosource still applies some of its technology to textiles, like odor-fighting kitchen towels, but this idea never worked for socks. The chemical application cost too much to be competitive, and you had to apply such large quantities of the finish that it made the socks too brittle. They’d fall apart after you ran a few miles in an ordinary pair of sweat socks, Johnston says.

“What looks great in the lab…when you go into the real world, sometimes you get into a real-world manufacturing site, you just don’t come out with what you thought you had,” Johnston says. “We spent a lot of time trying to put square pegs into round holes.”

Simon Johnston

The new variation on this bug-killing textile idea is taking shape at a Bellevue, WA-based startup called Antimicrobial Technologies Group. The company, led by Johnston and co-founder Pam Goldschmidt, has raised a modest $500,000 from friends and family to pursue their renewed bug-killing vision in socks. But the company isn’t focusing on just any kind of sock—it has its sights on people suffering from diabetic foot ulcers.

Why? The diabetes epidemic is raging, of course, affecting an estimated 25 million people in the U.S. Many of them suffer from poor circulation in their extremities, which leads to sores that get infected. The antimicrobial polymer technology, licensed from the University of South Dakota, is designed to overcome some of the previous challenges that made antimicrobial socks impractical. The chemical compounds embedded in these socks now come in such a potent dose that these socks look (and smell) just like any fresh cotton sock off the shelf, Goldschmidt says. The cost of the technology has come down so fast that the new socks can be mass-produced for pennies on the dollar, and compete on price at $10 to $20 a pair, along with other compression socks sold to diabetics to help with circulation, Johnston says.

Johnston, 63, is betting these new socks will sell. He’s ordered a shipment of 15,000 pairs that he plans to start selling directly to consumers online as soon as April. He’s hoping to capture …Next Page »

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